Suture clip deployment devices

ABSTRACT

Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can them move distally to prepare to deploy the next suture clip.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/757,938, filed Dec. 23, 2015, now U.S. Pat. No. 10,188,383, whichclaims the benefit of U.S. Patent Application No. 62/096,749 filed Dec.24, 2014, the entire disclosures of which are incorporated by reference.

This application is also related to U.S. patent application Ser. No.14/868,741, filed Sep. 29, 2015; U.S. patent application Ser. No.14/543,240, filed Nov. 17, 2014; U.S. Pat. No. 9,017,347, issued on Apr.28, 2015; U.S. patent application Ser. No. 13/938,071, filed Jul. 9,2013; U.S. patent application Ser. No. 14/307,694, filed Jun. 18, 2014;U.S. patent application Ser. No. 14/329,797, filed Jul. 11, 2014; U.S.patent application Ser. No. 14/965,323, filed Dec. 10, 2015; and U.S.patent application Ser. No. 14/658,575, filed Mar. 16, 2015; all whichare incorporated by reference herein in their entireties.

FIELD

This disclosure relates to suture clips and devices and methods forsecuring sutures using suture clips.

BACKGROUND

Sutures are used for a variety of surgical purposes, such asapproximation of tissue and ligation of tissue. When placing sutures,the strand of suture material to be used typically has a needle affixedto one end which is passed (looped) through the tissue to beapproximated or ligated, forming a stitch. The stitch is then tensionedappropriately, and the two free ends of the suture loop, the needle endand the non-needle end, are knotted to retain the desired tension in thestitch. Forming knots in suture during open surgery is a simple matter,though time-consuming, but forming knots in sutures during endoscopicsurgery can require two surgeons to cooperate in a multi-step processwhich is performed with multiple instruments to pass the needle andsuture back and forth to tie the suture knot.

Suture locking devices that eliminate the need to tie knots in order tospeed up surgical procedures are known. Suture retainers or locks areused in place of suture knots to prevent passage of a suture end intoand through tissue and to maintain the tension applied to the suturematerial during a suturing procedure.

When using a method that employs a clip to secure sutures, the clip canbe delivered by advancing the clip along the suture lines to the area ofinterest, and then engaging the clip to the sutures such that the clipsecures the sutures in place. With the clip thus secured, the excesssutures can be cut and removed from the patient. However, deployment ofseveral suture clips during a procedure can be very time consuming,difficult to accomplish without error, and prone to inconsistenttensioning from one clip to the next. In light of the foregoing, thereis presently a need for improved systems for securing sutures withsuture clips.

SUMMARY

Disclosed herein are improved suture clip delivery devices that can beloaded with and deliver several suture clips to respective sutures insuccession without reloading the device with additional suture clips.Disclosed devices and methods can be useful for securing heart valverepair devices or valve replacement prostheses in or near the heart, forexample. The devices and methods can also be used for various othertypes of surgical procedures. The devices and methods disclosed hereincan eliminate the need for suture knots, thus reducing surgical time andexposure. Further, the disclosed devices and methods can improve theease of implantation because the clinician need not tie knots in thelimited space in and around the target anatomy.

An exemplary disk-shaped suture clip disclosed herein includes anannular outer body, one or more resiliently deformable flaps thatproject radially inwardly from the annular outer body and define asuture engagement aperture for frictionally engaging one or more suturespassing therethrough, and one or more tabs projecting radially outwardlyfrom the annular outer body. The suture clip is generally disk-shapedwith the outer body, flaps, and tabs being substantially coplanar whenthe suture clip in its natural configuration. The one or more tabsproject radially outwardly from the outer perimeter of the annular outerbody. In some embodiments, the clip includes two or more radiallyprojecting tabs spaced about the outer perimeter of the annular outerbody. The suture clip has a resiliently deformed configuration whenmounted on the delivery device, wherein the one or more resilientlydeformable flaps are deflected out of a plane defined by the annularouter body and the one or more tabs, such that the suture engagementaperture enlarges sufficiently to receive a mandrel of the device.

Some embodiments of suture clip delivery devices described hereincomprise a proximal handle portion including an actuation mechanism anda shaft portion including a mandrel loaded with plural suture clips. Themandrel has an inner lumen for receiving sutures, a proximal end portioncoupled to the actuation mechanism, and a distal end portion having adistal opening in communication with the inner lumen. The suture clipsare mounted annularly around the distal end portion of the mandrel. Thesuture clips are generally disk shaped and have a diameter oriented inthe radial dimension of the shaft portion and a thickness oriented inthe axial dimension of the shaft portion, wherein the thickness issubstantially smaller than the diameter.

The actuation mechanism causes the mandrel to move proximally relativeto the suture clips, such that a distal-most one of the suture clipsslides off of a distal end of the mandrel and onto one or more suturesextending into the distal opening of the mandrel. After the distal-mostone of the suture clips is deployed onto one or more sutures, theactuation mechanism causes the mandrel and a remaining portion of thesuture clips to move distally relative to the handle portion such that adistal-most one of the remaining portion of the suture clips is ready tobe successively deployed.

The shaft portion can also include a retainer positioned at leastpartially around the mandrel and coupled to the actuation mechanismindependently of the mandrel. The retainer is configured to restrict thesuture clips from moving proximally relative to the handle portion whenthe mandrel moves proximally relative to the handle portion. Theactuation mechanism causes the retainer to rotate relative to themandrel and the suture clips. This rotation can cause cutting of the oneor more sutures and/or can free the suture clips to move distally alongwith the mandrel relative to the handle portion.

The retainer can include at least one axially extending slot thatincludes a plurality of circumferentially extending notches. Theradially extending tabs on the suture clips can project into the axiallyextending slot in the retainer and can be positioned in respective onesof the circumferentially extending notches. The retainer can have afirst rotational position wherein the suture clip tabs are positioned inthe notches, such that axial motion of the suture clips relative to theretainer is restricted, and the retainer can have a second rotationalposition wherein the suture clip tabs are not positioned in the notchesand the suture clips are allowed to move axially relative to theretainer. In the second position, the clips can move distally along withthe mandrel to reset the device after each suture clip deployment.

In some embodiments, the shaft portion includes an electrical heatingelement positioned at a distal end of the mandrel and the heatingelement is configured to cut a suture after a suture clip is deployedonto the suture. The heating element can be coupled to a switch in thehandle portion that is activated for a short time when the actuator isdepressed.

A further understanding of the features and advantages of the disclosedtechnology will become apparent from a consideration of the followingdetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary suture clip delivery device.

FIG. 2 is an exploded view of the device of FIG. 1.

FIG. 3 is an enlarged view of a distal portion of FIG. 2, showing anexploded view of a distal end of a shaft portion of the device loadedwith several suture clips.

FIG. 4 is an enlarged view of a portion of FIG. 3 showing a suture clipretainer.

FIG. 5 is an enlarged view of a portion of FIG. 3 showing a supportmandrel supporting several suture clips.

FIG. 6 is a plan view of an exemplary suture clip that can be used withthe disclosed delivery devices.

FIG. 7 shows a distal end of the delivery device of FIG. 1 showingsutures inserted into device and ready for delivery of a suture cliponto the sutures.

FIG. 8 shows the distal end of the delivery device with sutures insertedinto device and the support mandrel retracted to cause a distal-mostsuture clip to be deployed onto the sutures.

FIG. 9 shows the distal end of the delivery device with the suture clipdeployed onto the sutures and the clip retainer rotated to cut off freeends of the sutures and release the suture clips from the retainer.

FIG. 10 shows the distal end of the delivery device after thedistal-most suture clip has been deployed onto the sutures and has beremoved from the delivery device, and after the support mandrel has beenadvanced again to advance the remaining suture clips such that the nextmost distal suture clip is ready to be deployed onto another suture orsutures.

FIG. 11 is an enlarged exploded view of a handle portion of the deliverydevice of FIG. 1.

FIGS. 12-15 are perspective views of an actuation mechanism within thehandle portion shown in FIG. 11, illustrating the motion of theactuation mechanism in four sequential positions.

FIGS. 16-19 are side views that correspond with the sequential positionsshown in FIGS. 12-15.

FIG. 20 shows another embodiment of suture clip deployment device.

FIG. 21 is an exploded view of the device of FIG. 20, showing suturesextending entirely through the shaft. Sutures can be pulled out throughthe rear end of the device.

FIG. 22 shows an exemplary snare for pulling sutures through the deviceof FIG. 21.

FIG. 23 is an exploded view of an exemplary suture clip deploymentdevice that includes an electrically powered heating system for cuttingsutures using heat.

FIG. 24 shows an electric heating element at the distal end of the shaftof the device of FIG. 23.

DETAILED DESCRIPTION

Described herein are devices and methods for securing sutures withsuture clips. FIGS. 1-5 and 7-19 illustrate an exemplary suture clipdeployment device 2. The device 2 can be loaded with one or more sutureclips, such as the exemplary disk-shaped suture clip 18 shown in FIG. 6,and can be used to deploy loaded suture clips in succession onto one ormore sutures, such as during implantation of a prosthetic device withinthe heart. While any of the disclosed suture clips can be used to securea single suture, or can be used to secure plural sutures or suturesegments at the same time, this description proceeds with reference tonon-limiting examples wherein each suture clip is deployed onto twosutures segments for ease of description only.

As shown in FIG. 1, the device 2 comprises a handle portion 4 that canbe held and actuated by a user and a shaft portion 6 that can beinserted into the body, at least partially, to deploy suture clips ontosutures in hard to reach regions within the body in a minimally invasivemanner. The handle portion 4 includes an actuator, or trigger, 8 thatcan be depressed by a user to deploy a suture clip onto one or moresutures and cut of the free end of the sutures. Releasing the actuator 8can cause another suture clip loaded in the device 2 to move forward andbe ready for deployment the next time the actuator is depressed. Thedistal end of the shaft portion 6 is not shown in FIG. 1. The device 2can be used with any suitable suture clips, such as the suture clips 18described herein or their equivalents.

The disclosed suture clip delivery devices can be used for manydifferent procedures where sutures are used, such as to secure anartificial heart valve or other prosthetic device with the heart, torepair or treat native organs or tissues, to close openings or occludelumens within the body, or for other procedures. Additional informationregarding procedures for which the disclosed suture clip deliverydevices can be used, and other information regarding exemplary sutureclips and suture clip delivery devices, are disclosed in the followingreferences, the entire contents of which are expressly incorporated byreference herein: U.S. Pat. Nos. 6,626,930; 7,094,244; 7,083,628; and7,381,210; and U.S. Patent Application Publication Nos. 2007/0005079 and2013/0165953.

FIG. 2 is an exploded view of the device 2. The distal portion 10 of theshaft portion 6 is shown at the right of FIG. 2, and is furtherillustrated in FIGS. 3-5. The shaft portion 6 includes a tubular outershaft 12 that is fixed at its proximal end to the housing 20 of thehandle portion, a suture clip retainer 14 that positioned within theouter shaft 12, a clip support mandrel 16 positioned within the retainer14, and a plurality of suture clips 18 mounted on the mandrel 16 withinthe retainer 14.

As shown in more detail in FIGS. 11-19, the handle portion 4 includesleft and right portions of a housing 20, the actuator 8, gears 22, cam24, cam follower 26, follower spring 28, and bracket 80. While theactuation of the device 2 is described in more detail below, thefollowing brief summary is provided here. Depressing the actuator 8rotates the gears 22 and cam 24, which causes the cam follower 26 tomove proximally (rearwardly), pulling the mandrel 16 proximally alongwith the cam follower. The rotation of the gears 22 can also turn thebracket 80, which causes the retainer 14 to rotate. Rotation of theretainer 14 cuts off free ends of the sutures to which a suture clip 18is secured and also releases the tabs of the suture clips from notchesin the retainer so that the clips can slide distally through theretainer after each suture clip is deployed. Releasing the actuator 8then allows the spring 28 to push the cam follower 26 and supportmandrel 16 distally, and also rotates the cam 24, gears 22, and bracket80 in the opposite direction, causing the retainer to rotate back to itsoriginal position. The Actuator 8 can pivot about a point 84 near thebottom of the handle and be biased forward with a spring or the like.

FIG. 3 shows the distal end of the shaft portion 6 with the variouscomponents exploded, though the outer shaft 12, retainer 14, and mandrel16 all terminate with their distal ends at about the same axial positionin the assembled device, as shown in FIG. 7.

The distal end of the retainer 14 is shown in more detail in FIG. 4. Theretainer 14 also includes a proximal portion that extends through theouter shaft 12 and into the handle portion 4, and is coupled to theactuation mechanism so that the retainer can be rotated about the shaftaxis when the actuator 8 is depressed. The retainer 14 is generallytubular and includes an inner lumen through which the mandrel 16extends. The distal end of the retainer, as shown in FIG. 4, includes anannular distal collar 30 and one or more elongated slots 34 that extendproximally from behind the collar 30. Each of the slots 34 includes aplurality of notches 36 at regularly spaced intervals along the axiallength of the slot. In the illustrated example, the retainer 14 includestwo slots 34 on diametrically opposite sides of the retainer. Thenumber, size, and spacing of the slots 34 can correspond to theconfiguration of the suture clips that the device can be used with. Forexample, the suture clips 18 (see FIGS. 5 and 6) include two opposingtabs 54 that correspond with the two opposing slots 34 in the retainer.In other embodiments, suture clips with only one tab may be used, and acorresponding retainer with one slot 34 can be used. In still otherembodiments, suture clips with three or more tabs can be used with aretainer that has a corresponding number of slots in a correspondingangular orientation. Similarly, the number of the notches 36 cancorrespond to the number of suture clips 18 that can be loaded into thedevice. In various embodiments, the retainer 14 can have any number ofnotches 36 along each slot 34 to allow the device to be loaded with acorresponding number of suture clips.

FIG. 5 shows the distal end of the mandrel 16 with several suture clips18 loaded on it. The mandrel 16 can have a generally rectangularcross-sectional shape, as shown, or other non-circular cross-sectionalshapes. The mandrel 16 can also include an inner lumen 44 that extendsat least partially through the mandrel from the distal end of themandrel. In some embodiments, the inner lumen extends all or most of theway through the mandrel 16 with a proximal exit within or adjacent thehandle portion 4. The mandrel 16 can also include a lateral opening 46near the distal end of the mandrel that communicates with the innerlumen 44.

The mandrel 16 has an outer profile that is shaped to fit through thesuture clips 18 with a friction fit as shown in FIG. 5. When loaded onthe mandrel 16, the suture clips are resiliently deformed such that theypinch onto the sides 48 of the mandrel while the top and bottom surfaces50 of the mandrel can be positioned closely with inner surfaces of thesuture clips to keep them snuggly supported on the mandrel with minimalplay allowed in the directions perpendicular to the shaft axis.

FIG. 6 is a plan view of an exemplary suture clip 18. The clip 18 has athin thickness, or depth, (dimension perpendicular to the page in FIG.6) relative to its major dimension, or diameter. The thickness can berelatively uniform for the whole clip, and can be substantially smallerrelative to the diameter of the clip (left-to-right dimension in FIG.6), such as less than 25% of the diameter, less than 15% of thediameter, less than 10% of the diameter, and/or less than 5% of thediameter.

The clip 18 is generally disk shaped with two suture engagement flaps 56that project inwardly toward each other and define a suture engagementslot 58. The suture engagement slot 58 can include a tortuous portion 60at either end to prevent sutures that are pinched between the flaps 56in the suture engagement slot 58 from sliding laterally out of the slot58 into either of the arcuate slots 62 that extend from the ends of theslot 58. The arcuate slots 62 space the flaps 56 from an outer annularportion 64 of the clip 18 and allow the flaps 56 to articulate out ofthe plane of FIG. 6 while the outer annular portion 64 stays generallyin or near the plane of the FIG. 6. The arcuate slots 62 can includeenlarged, rounded end portions 66 that reduce stress concentrations inthe clip material around them when the flaps 56 are resiliently deformedout of plane. FIG. 6 also shows two tabs 54 at diametrically oppositesides of the clip 18.

The suture clips 18, and other suture clip embodiments, can be made froma variety of materials including, for example, nickel-titanium alloys,shape-memory alloys, stainless steel, titanium, various plastics, andother biologically-compatible materials. Exemplary suture clips can beformed from shape memory and/or pseudoelastic materials such as nitinol.In some embodiments, the suture clips can be formed from nitinol (e.g.,with an alloy of nickel at 54.5-57% by weight with titanium accountingfor the balance except for residual amounts (less than 0.05% each) ofoxygen, carbon, and hydrogen) or another shape memory and/orpseudoelastic material, with the suture clips formed so that the clipassumes its closed position (e.g., the flat position shown in FIG. 6)when in the austenite condition (i.e., when generally unstressed at bodytemperature). The nitinol can have an austenite finish temperatureselected to match the particular application. For example, an austenitefinish temperature of −5 degrees to +15 degrees Celsius may be selected.

A suture clip can be formed from material that will assume itsmartensite condition when subjected to sufficient stress, such as thestress applied to the clip's engagement flaps 56 and annular outer body64 when the suture clip is mounted onto the mandrel 16, as shown in FIG.5. In such an embodiment, the mandrel 16 applies stress to theengagement flaps 56, forcing the engagement flaps to open wide enough toreceive the mandrel through the slot 58. The stressed material,including the bent material where the engagement flaps 56 join theannular outer body 64, is forced into its martensite condition. When thestress is removed, such as when the mandrel slides out from thedistal-most clip 18, as depicted in FIG. 8, the material returns to itsaustenite condition so that the annular outer body 64 and the engagementflaps 56 assume their flat shape shown in FIG. 6.

When the clips 18 are loaded onto the mandrel 16, as shown in FIG. 5,the flaps 56 are resiliently deformed out of plane and the slot 58enlarges wide enough to accommodate the width of the mandrel. The clips18 are loaded on the mandrel 16 with the flaps 56 projecting proximally,as shown, such that the clips can more readily slide distally along andoff of the mandrel. Having the flaps 56 extend proximally also allowsthe distal-most clip 18 to be positioned with the outer annular portion64 and flaps 54 at the distal end of the mandrel when ready fordeployment, as shown in FIG. 7.

The clips 18 when loaded on the mandrel 16 can be spaced apart atregular axial intervals that correspond to the axial spacing of thenotches 36 in the axial slots 34 of the retainer 14 (see FIG. 4). Whenthe device 2 is assembled with the clips 18 loaded, as illustrated inFIG. 7, the tabs 54 of the clips are positioned in respective ones ofthe notches 36 and adjacent to or touching the proximal surfaces 38 ofthe notches. As shown in FIG. 7, the distal-most clip 18 can bepositioned with its tabs 54 in recesses 32 formed in the distal collar30 of the retainer 14. The recesses 32, like the surfaces 38, provide abackstop behind the tabs 54 that block the clips 18 from movingproximally relative to the retainer, but allow the clips to movedistally relative to the retainer.

FIG. 7 shows the distal end of the shaft portion 6 of the device 2 in aposition ready to deploy the distal-most clip 18 onto sutures 70. Thesutures 70 have been direct into a position where they extend into theinner lumen 44 of the mandrel 16, out through the lateral opening 46 ofthe mandrel, through a lateral opening 42 in the retainer 14, andthrough a lateral opening 72 in the outer shaft 12. These lateralopenings can be generally aligned in this configuration. The free ends74 of the sutures are shown projecting from the lateral opening 72 inthe outer shaft 12 in FIG. 7. The lateral opening 42 in the retainer 14is shown in FIG. 4. The lateral opening 42 can alternatively be locatedon the opposite side of the retainer from where it is shown in FIG. 4,between the symmetrical slots 34 on opposite sides of the retainer. Inthe configuration shown in FIG. 7, the lateral openings 46, 42 and 72are aligned so the sutures 70 can be passed through them. Passing thesutures through the openings 46, 42, and 72 can be performed in anysuitable manner, such as by using a snare to pull the sutures throughthe openings. Passing the sutures through the lateral openings 46, 42,72 positions the distal-most clip 18 around the sutures 70, but thedistal-most clip is not yet secured onto the sutures. The free ends 74of the sutures can then be grasped and a desired tension can be appliedto the sutures 70 with the distal end of the shaft portion 6 and thedistal-most clip 18 being positioned adjacent to the location where thesutures 70 exit from tissue, a prosthetic device, or other substrate.

Once a desired positioning of the distal-most clip 18 relative to thesutures 70 is obtained and a desired tension is applied to the sutures70, the distal-most clip can be deployed onto the sutures 70. As shownin FIG. 8, to deploy the distal-most clip 18 onto sutures, the actuator8 of the device 2 is depressed to cause the mandrel 16 to moveproximally relative to the shaft portion 6 and the clips 18. As themandrel 16 moves proximally, the tabs 54 of the clips 18 carried on themandrel contact the proximal surfaces 38 of the notches 36 of theretainer 14 and the proximal surface of the recess 32 in the collar 30to prevent the clips from moving proximally with the mandrel. Thiscauses the mandrel 16 to slide through the clips 18 while the clips areheld relatively stationary. The mandrel 16 moves proximally about thedistance of one interval between two adjacent clips. As shown in FIG. 8,the mandrel 16 has moved proximally such that the distal end of themandrel is now in line with the second-most distal clip 18. When themandrel exits the distal-most clip, the flaps 56 of the distal-most clipresiliently close back to the flat position (FIG. 6) and pinch thesutures 70, as shown in FIG. 8. The sutures are desirably engaged in theportion of the slot 58 between the two tortuous portions 60 (see FIG.6).

As shown in FIG. 9, depression of the actuator 8 can also cause theretainer 14 to rotate about the shaft axis relative to the outer shaft12, the mandrel 16, the clips 18, and the rest of the device 2. Thisrotation can occur after the proximal motion of the mandrel or the twomotions can overlap in time. For example, the rotational motion of theretainer can begin while the proximal motion of the mandrel in partiallycomplete. The rotational motion of the retainer 14 can have two effects.First, the shearing motion between the lateral opening 42 of theretainer and the lateral opening 72 of the outer shaft can cut off thefree ends 74 of the sutures 70. Second, the rotational motion of theretainer 14 causes the tabs 54 of the clips 18 to exit the notches 36 ofthe retainer and become positioned in the open parts of the axial slots34 (FIG. 9). This allows the clips 18 to then move axially relative tothe retainer 14 as the tabs 54 can travel along the axial slots 34. Atthe distal end of the retainer 14, the tabs 54 of the distal-most clip18 also move angularly about the recesses 32 in the collar 30.

With the free ends 74 of the sutures cut off and the distal-most clip 18secured onto the sutures 70, the device 2 can be retract from the clipdeployment site, allowing the distal-most clip to exit the distal end ofthe device and remain secured to the sutures at the deployment site.

As shown in FIG. 10, when the actuator 8 is released after a suture cliphas been deployed, the mandrel 16 moves distally relative to theretainer 14 and the outer shaft 12, and the mandrel carries theremaining clips 18 distally along with it as the tabs 54 travel distallyalong the axial slots 34 in the retainer. The notches 36 can optionallyinclude an angled or rounded distal surface 40 to facilitate the tabs 54moving distally from adjacent one notch 36 to adjacent the next notch36. The distal surfaces 40 can reduce the risk of the tabs 54 gettingcaught on the corners of the notches as the clips slide distally throughthe slots 34. The formerly second-most distal clip 18 then becomeslocated at the distal end of the shaft inside the collar 30. Releasingthe actuator 8 also causes the retainer to rotate back the oppositedirection, returning to its original position. As the retainer rotates,the tabs 54 move back into the notches 36, and the device returns to theready position shown in FIG. 7, without the sutures 70. The processillustrated in FIGS. 7-10 can then be repeated to deploy the remainingsuture clips 18 to other sutures.

FIGS. 12-15 are perspective views of the actuation mechanism in thehandle portion 2 showing four stages of the actuation sequence, whichcorrespond generally with the four configurations shown in FIGS. 7-10.FIGS. 16-19 are side views of the actuation mechanism that correspond tothe perspective views shown in FIGS. 12-15.

In the position shown in FIGS. 12 and 16, the actuator 8 is in itsforward position and not depressed. The mandrel 16 and the retainer 14are in the position shown in FIG. 7. In this position, the cam follower26 in its forward or distal position and the following spring 28attached to a proximal aspect 102 of the cam follower is not compressedor is in its minimally compressed state. The proximal end of the mandrel16 is fixed to a distal aspect 100 of the cam follower 26. The proximalend of the retainer 14 extends into the handle portion 4 and includes aradial projection 104 that extends into a circumferential slot 106 inthe bracket 80. In the view of FIG. 16, the bracket 80, gears 22, andcam 24 are in their most clockwise rotational position, in which a firstend 108 of the slot 106 is adjacent to or contacting the radialprojection 104 of the retainer and a portion of the cam's radial bearingsurfaces 96 with a minimum radius is in contact with the cam follower'slateral aspects 98.

With reference to FIG. 11, the cam 24 includes rectangular (or othershaped) lateral pegs 92 on either side that fit into correspondinglyshaped openings 88 in the gears 22, which fixes the rotational motion ofthe cam 24 to that of the gears 22. The cam 24 further includes lateralprojections 94 (e.g., cylindrical shaped as shown) on either side of therectangular projections, one of which fits through an opening 95 in thebracket 80, and which lateral projections 94 are rotationally engagedwith the handle housing 20 to allow the cam to rotate but not translateperpendicular to its rotational axis.

One or both of the gears 22 can also include a lateral projection 90that is offset radially from the gear's rotation axis and which lateralprojection 90 fits into a hole 91 in the bracket 80 to fix the bracket'srotational motion to that of the gears 22 and the cam 24. When theactuator 8 is depressed (moves to the right in FIG. 16), the actuator'supper teeth 82, which are engaged with the teeth 86 of the gears 22,cause the gears, cam, and bracket to rotate in a corresponding manner(counter-clockwise in FIG. 16).

As shown in FIGS. 13 and 17, when the cam 24 rotates counter-clockwise,the cam's radial bearing surfaces 96 slide across the later aspects 98of the cam follower 26, the portion of the radial bearing surfaces incontact in contact with the lateral aspects 98 gradually increases inradius, pushing the cam follower reawardly (proximally) and compressingthe spring 28. As shown in FIG. 13, the radial bearing surfaces 96 mayincrease in radius over a selected circumferential portion, such asbetween the lines marked 112 and 114. The circumferential portions ofthe radial bearing surfaces 96 beyond the lines 112 and 114 can have acontinuous radius, with the portion to the left of line 112 in FIG. 13having a smaller radius and the portion below line 114 having a greaterradius. Thus, the cam follower 26 and the mandrel 16 only move axiallywhen the region of the radial bearing surfaces 96 between the lines 112and 114 are sliding across the lateral aspects 98. This can allow themandrel 16 to remain axially still while further depression of theactuator 8 causes the bracket 80 to rotate the retainer 14, and viceversa. In the position of FIGS. 13 and 17, the cam follower 26 andmandrel 16 are at their maximally proximal position, but the retainer 14has not begun to rotate yet, corresponding to the position shown in FIG.8. In this position, the bracket 80 has rotated to cause the lateralprojection 104 of the retainer 14 to traverse the slot 106 from thefirst end 108 (in FIGS. 12 and 16) to the second end 110 of the slot.

As shown in FIGS. 14 and 18, further depression of the actuator 8 andcounter-clockwise motion of the bracket 80 causes the second end 110 ofthe slot 106 to pivot the lateral projection 104 downward about theshaft axis, rotating the retainer 14. During the rotation of theretainer 14, a uniform radius portion of the radial bearing surfaces 96can be in contact with the cam follower 16, keeping the mandrel 16stationary. FIGS. 14 and 18 show a maximum depression of the actuator 8,with maximum rotation of the retainer 14, which corresponds to theposition shown in FIG. 9.

As shown in FIGS. 15 and 19, subsequent releasing of the actuator 8causes (via resilient biasing forces applied to the actuator) theactuator to recoil back out of the housing 20 (to the left in FIG. 19)and causes the gears 22, cam 24, and bracket 80 to rotate clockwise.During the initial portion of this recoil motion, the bracket slot 106moves over the lateral projection 104 without rotating the retainer 14,while at the same time the variable radius portion of the cam's radialbearing surfaces 96 slides over the lateral aspects 98 of the camfollower 26 to allow the compressed spring 28 to push the cam followerand mandrel back distally to their original position as in FIGS. 12 and16. At the point shown in FIGS. 15 and 19, which corresponds to theposition shown in FIG. 10, the mandrel 16 has moved back distally andthe first end 108 of the bracket slot 106 contacts the lateralprojection 104 and begins pivoting it upward, thereby rotating theretainer 14 back toward its original position. Further recoiling of theactuator 8 returns the mechanism back to the position shown in FIGS. 12and 16, which corresponds to the position of FIG. 7.

FIGS. 20-24 illustrate another suture clip delivery device 200 that canbe loaded with a plurality of suture clips, such as the clips 18, andused to successively deploy plural clips onto sutures, similar to thedevice 2 disclosed herein. As shown in FIG. 20, the device 200 includesa handle portion 202 and a shaft portion 204. The shaft portion 204 caninclude an outer shaft, retainer, and mandrel similar to those describedwith device 2, except that in the device 200 the sutures are drawn allthe way through the shaft and out through a proximal opening 206 in thehandle portion, rather than out through a lateral opening in the shaft.The device 200 can also include a suture tensioner 208 that can berotated to adjust the tension in the sutures, as well as a suturetension monitoring system with tension or torque display 210 on thehandle. As shown in FIG. 21, sutures 216 are passed through the shaftportion 204, through a winding portion 218 in the suture tensioner 208,and out through the proximal opening 206. The suture tensioner 208includes the winding portion 218, which passes laterally through anopening 214 in one side of the handle housing 212, and an external knobportion that can be manually rotated to wind the sutures 216 around thewinding portion 218 until a desired tension is applied to the sutures. Asensor coupled to the tensioner 208 can measure the tension or torqueapplied and cause the tension/torque to be displayed on the display 210.Alternatively, a user can pull on the free ends of the suturesprotruding from the opening 206 to adjust the tension.

FIG. 22 shows an exemplary snare 230 that can be used to pull thesutures 216 through the device 200. The snare 230 includes a rigid shaft232 and a flexible loop 234 at the distal end of the shaft. The loop 234can include angled portions 236 and 238 that allow the loop toresiliently bias apart toward the opening position shown, and thencollapse to a flat shape to pass through the shaft of the device 200.The snare 230 can be passed through the device 200 with the collapsedloop 234 being inserted into the proximal opening 206, through thetensioner 208, and through the shaft portion 204 (e.g., through themandrel 264, retainer 262, clips 272, and outer shaft 260) and outthrough the distal end of the device 266 (see FIG. 23). When the loop234 exits the distal end of the device 200, the loop resiliently opensto form opening 240. Sutures can then be passed through the opening 240.Retracting the snare 230 proximally back through the device 200 thencauses the loop 234 to collapse and capture the sutures as the suturesare pulled through the device and out through the proximal opening 206.The snare can then release the sutures.

Once sutures are loaded through the device 200, the device can beadvanced over the sutures distally toward the location where the suturesexit the tissue or other material to locate the distal-most suture clipadjacent that location. Desired tension can then be applied to thesutures by rotating the tensioner knob 208 and/or pulling on the freeends of the sutures. The distal-most suture clip can then be deployedonto the sutures using an actuation mechanism similar to that shown inFIGS. 7-19. However, the device 200 can cut off the free ends of thesutures using a heating element located at the distal end of the shaftrather than using the shearing motion between the retainer and the outershaft as in the device 2.

As shown in FIGS. 23 and 24, the device 200 can include an electricalheating element 268 at the distal end of the shaft that includes aheater tip 270 located adjacent to and/or passing through a lateralopening 276 in the mandrel 264. The heater tip 270 is sufficiently closeto the sutures that pass through the distal opening 274 in the mandreland pass through the axial length of the inner lumen of the mandrel. Theheating element 268 is electrically coupled via wires 256 to a heaterswitch 252 located in the handle portion 202 and a battery 254 locatedin the handle portion and/or an external power source. The heater switch252 can be activated when the actuator 250 is depressed and can providepower from the battery 254 to the heating element 268. When activated,the heater tip 270 rapidly heats up and cuts (e.g., melts, burns, etc.)the sutures just behind the distal-most suture clip 272 that is deployedonto the sutures. The heater tip 270 can heat up in about one second insome examples, and can also cool down in about one second after thepower to the heating element is ceased. This method of cutting thesutures can provide a clean end of the cut sutures without frayedfibers, which can occur after a blade-type cut of a suture. The heat canmelt or fuse the suture fibers together at the free end.

In alternative embodiments of the devices disclosed herein, a sutureclip can be deployed onto sutures without cutting the suturesimmediately thereafter. After a suture clip is deployed onto thesutures, the device can be retracted proximally over the free ends ofthe sutures to allow a user to inspect the clip deployment location toverify a clip was deployed and check the accuracy and viability of thedeployment clip. If the clip deployment is undesirable, the clip can beremoved and a new clip can be deployed to the sutures before they arecut. The deployed clip can also be adjusted and/or the suture tensioncan be adjusted before cutting off the free ends of the sutures. If theclip deployment is sufficient, the device can be moved back distallyover the sutures to adjacent the deployed clip, and the device can befurther used to cut off the free ends of the sutures. In suchembodiments, the device can include a double actuation mechanism toindependently deploy the clip and re-cock the device with one usermotion, and then cut the sutures with another user motion.Alternatively, another device can be used to cut the sutures after thedeployment device has been removed.

In some embodiments, a vacuum system can be used to draw free endssutures into the lumen of the mandrel. A vacuum source can be providedexternal to the device, or an internal vacuum source can be provided,such as within the handle portion. A hose or other conduit can couplethe vacuum source to the shaft portion in order to draw air proximallythrough the shaft portion and create a low pressure region within theshaft that draws free ends of sutures in. In some embodiments, the shaftportion can include an adjustable door that covers and uncovers alateral opening passing through the outer shaft, retainer and mandrel.When the door is closed, low pressure can be created inside the mandrelto draw in sutures. When the door is opened, the sutured can be graspedand pulled out laterally through the door. In other embodiments, thevacuum can be used to draw sutures all the way through the mandrel intothe handle portion and/or out through a proximal opening in the handleportion. A suture clip deployment device can be configured to activatethe vacuum source when the actuator is depressed, or can include aseparate control for the vacuum source. Using a vacuum system to draw insutures can eliminate the need for a snare, or can be used inconjunction with a snare.

In some embodiments, the device can comprise a vacuum monitoring systemthat determines and displays the pressure/vacuum level in the shaftportion and/or the amount or status of vacuum being generated or appliedfrom a vacuum source. In some embodiments, an indicator on a display,such as the display 210, can indicate whether or not the vacuum is beingapplied, while in other embodiments, a level of vacuum or pressure canbe displayed.

In some embodiments, the device can comprise a suture clip monitoringsystem that tracks/determines and displays the number of clips remainingloaded in the device. The device can comprise a display, such as therear display 210, that shows how many clips remain. In some embodiments,when the last clip has been deployed, the clip monitoring system cancause the device to become locked such that actuator cannot be pulled.In some embodiments, the clip monitoring system can also display alock-out indicator on the display. The display can be mechanical orelectronic, analog or digital.

In some embodiments, the devices disclosed herein can be disposableafter being used during a surgery and/or when all the loaded clips havebeen deployed. In other embodiments, the device can be cleaned and/orreloaded with clips and reused.

In some embodiments, the device can be reloaded with additional sutureclips by removing the empty mandrel, or just the distal portion of themandrel, and replacing it with a new mandrel or mandrel portion that isloaded with additional suture clips. For example, the mandrel cancomprise a distal piece and a proximal piece that readily disconnect andreconnect. The distal piece can be removed and replaced with a newdistal piece loaded with additional suture clips. In other embodiments,the mandrel and the retainer (or distal parts thereof) can be replacedtogether. In other embodiments, the entire shaft portion (of a distalpart thereof) can be replaced to reload the device. In still otherembodiments, additional suture clips can be placed onto the existingmandrel to reload the device.

In some embodiments, any of the devices disclosed herein can include avisual monitoring system configured to capture visual information fromor near the distal end of the shaft and transfer the captured visualinformation to a proximal visual display. For example, the device caninclude a camera or endoscope positioned near the distal end of theouter shaft that is coupled via wiring to an adaptor extending from thehandle and configured to be coupled to an external monitor that a usercan view to assist in the clip deployment process.

GENERAL CONSIDERATIONS

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosure may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of thedisclosure is at least as broad as the following claims. We thereforeclaim all that comes within the scope of the following claims.

What is claimed is:
 1. A method for deploying a suture clip onto asuture, comprising: causing a free end of a suture to enter into adistal end portion of an inner lumen of a mandrel of a suture clipdeployment device; and causing the mandrel to move proximally relativeto a plurality of annular suture clips mounted around an outer surfaceof the mandrel such that a distal-most one of the suture clip slidesdistally off of a distal end of the mandrel and onto the suture suchthat the distal-most one of the suture clips resiliently secures to thesuture; wherein the plurality of annular suture clips are generally diskshaped and are mounted around the outer surface of the mandrel such thata diameter of each suture clip is oriented perpendicular to the proximalmotion of the mandrel and a thickness of each suture clip is alignedwith the proximal motion of the mandrel, wherein the thickness issmaller than the diameter; wherein the suture clips each comprise one ormore tabs that extend outwardly perpendicular to the proximal motion ofthe mandrel, and causing the mandrel to move proximally causes the oneor more tabs of each suture clip to contact a retainer of the sutureclip deployment device, which retainer prevents the suture clips frommoving proximally along with the mandrel.
 2. The method of claim 1,further comprising, after causing the mandrel to move proximallyrelative to a plurality of annular suture clips, causing the retainer torotate to a position wherein the one or more tabs of each suture clipare not restricted by the retainer from moving distally along with themandrel.
 3. The method of claim 2, further comprising, after thedistal-most one of the suture clip slides distally off of a distal endof the mandrel and onto the suture, causing the mandrel and a remainingportion of the suture clips to move distally relative to the retainersuch that the one or more tabs of each of the remaining portion of thesuture clips moves distally along a slot in the retainer.
 4. The methodof claim 1, wherein causing the free end of the suture to enter into thedistal end portion of the inner lumen of the mandrel of the suture clipdeployment device comprises: passing a snare distally through the sutureclip deployment device such that a distal end of the snare projects froma distal end of the suture clip deployment device; inserting the suturethrough an opening in the distal end of the snare; and retracting thesnare proximally through the suture clip deployment device to pull thesuture through the suture clip deployment device.
 5. The method of claim4, wherein the suture is placed through a tensioner of the suture clipdeployment device and the method further comprises rotating thetensioner to adjust tension in the suture before the distal-most one ofthe suture clip slides distally off of a distal end of the mandrel andonto the suture.
 6. The method of claim 1, further comprising causing anelectrical heating element positioned adjacent the distal end portion ofthe inner lumen of the mandrel to cut the suture after the distal-mostone of the suture clip slides distally off of a distal end of themandrel and onto the suture.
 7. A method for deploying a suture cliponto a suture, comprising: causing a free end of a suture to enter intoa distal end portion of an inner lumen of a mandrel of a suture clipdeployment device; and causing the mandrel to move proximally relativeto a plurality of annular suture clips mounted around an outer surfaceof the mandrel such that a distal-most one of the suture clip slidesdistally off of a distal end of the mandrel and onto the suture suchthat the distal-most one of the suture clips resiliently secures to thesuture; wherein the plurality of annular suture clips are generally diskshaped and are mounted around the outer surface of the mandrel such thata diameter of each suture clip is oriented perpendicular to the proximalmotion of the mandrel and a thickness of each suture clip is alignedwith the proximal motion of the mandrel, wherein the thickness issmaller than the diameter; wherein causing the free end of the suture toenter into the distal end portion of the inner lumen of the mandrel ofthe suture clip deployment device comprises: passing a snare distallythrough the suture clip deployment device such that a distal end of thesnare projects from a distal end of the suture clip deployment device;inserting the suture through an opening in the distal end of the snare;and retracting the snare proximally through the suture clip deploymentdevice to pull the suture through the suture clip deployment device; andwherein the suture is placed through a tensioner of the suture clipdeployment device and the method further comprises rotating thetensioner to adjust tension in the suture before the distal-most one ofthe suture clip slides distally off of a distal end of the mandrel andonto the suture.
 8. The method of claim 7, wherein the suture clips eachcomprise one or more tabs that extend outwardly perpendicular to theproximal motion of the mandrel, and causing the mandrel to moveproximally causes the one or more tabs of each suture clip to contact aretainer of the suture clip deployment device, which retainer preventsthe suture clips from moving proximally along with the mandrel; andfurther comprising, after causing the mandrel to move proximallyrelative to a plurality of annular suture clips, causing the retainer torotate to a position wherein the one or more tabs of each suture clipare not restricted by the retainer from moving distally along with themandrel.
 9. The method of claim 8, further comprising, after thedistal-most one of the suture clip slides distally off of a distal endof the mandrel and onto the suture, causing the mandrel and a remainingportion of the suture clips to move distally relative to the retainersuch that the one or more tabs of each of the remaining portion of thesuture clips moves distally along a slot in the retainer.
 10. The methodof claim 7, further comprising causing an electrical heating elementpositioned adjacent the distal end portion of the inner lumen of themandrel to cut the suture after the distal-most one of the suture clipslides distally off of a distal end of the mandrel and onto the suture.